Gilbard 2008.
| Methods |
Study design: randomized, parallel‐group, controlled trial Study site(s): not reported if single‐ or multi‐center Number randomized (total and per group): 61 participants Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N |
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| Participants |
Baseline characteristics Country: not reported Age (mean ± SD, range): not reported Gender: not reported Inclusion criteria: 1. Sjögren’s syndrome Exclusion criteria: not reported Equivalence of baseline characteristics? (Y/N): N |
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| Interventions |
Intervention #1 (treatment group): omega‐3 supplement (TheraTears Nutrition), containing fish oil 1600 mg (with EPA 450 mg and DHA 300 mg) and flaxseed oil 1000 mg Intervention #2 (control group): placebo ‐ wheat germ oil (dose not reported) Length of follow‐up: not reported Notes: none |
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| Outcomes | Primary and secondary outcome measures were not clearly distinguished Outcomes specified: percentage change from baseline in symptoms of dry eye; symptoms of dry mouth; unstimulated and stimulated salivary flow Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes, if any): none |
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| Notes |
Study dates: not reported Funding source(s): not reported Conflicts of interest: not reported Publication language: English Registered on clinical trials registry? (Y/N): N |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation was not reported |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Masking of participants and personnel was not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Masking of outcome assessors was not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Numbers randomized to each group, lost to follow‐up, and excluded were not reported |
| Selective reporting (reporting bias) | Unclear risk | No access to study protocol or clinical trials registry |
| Other bias | Unclear risk | This study was published in abstract form only, and further publication was not identified |